BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

235 related articles for article (PubMed ID: 11010726)

  • 1. Investigational new drug applications; amendment to clinical hold regulations for products intended for life-threatening diseases and conditions. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Jun; 65(106):34963-71. PubMed ID: 11010726
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Investigational new drug applications; clinical holds--FDA. Direct final rule.
    Fed Regist; 1998 Dec; 63(239):68676-8. PubMed ID: 10187558
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Investigational new drug applications; clinical holds; companion document to direct final rule--FDA. Proposed rule.
    Fed Regist; 1998 Dec; 63(239):68710-2. PubMed ID: 10187560
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Expanded access to investigational drugs for treatment use. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Aug; 74(155):40900-45. PubMed ID: 19691173
    [TBL] [Abstract][Full Text] [Related]  

  • 5. New drug applications; drug master files. Food and Drug Administration, HHS. Final rule.
    Fed Regist; 2000 Jan; 65(8):1776-80. PubMed ID: 11010656
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Investigational new drug applications and new drug applications--FDA. Final rule.
    Fed Regist; 1998 Feb; 63(28):6854-62. PubMed ID: 10177736
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
    Rossen BR
    Food Drug Law J; 2009; 64(1):183-223. PubMed ID: 19998746
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Jul; 73(136):40453-63. PubMed ID: 18850678
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Charging for investigational drugs under an investigational new drug application. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Aug; 74(155):40871-900. PubMed ID: 19691172
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Investigational new drug application; exception from informed consent; technical amendment--FDA. Final rule.
    Fed Regist; 1997 Jun; 62(115):32479. PubMed ID: 10169828
    [TBL] [Abstract][Full Text] [Related]  

  • 11. New drug, antibiotic, and biological drug product regulations; accelerated approval--FDA. Final rule.
    Fed Regist; 1992 Dec; 57(239):58942-60. PubMed ID: 10123232
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2003 Jun; 68(117):36675-712. PubMed ID: 12814136
    [TBL] [Abstract][Full Text] [Related]  

  • 13. New drug applications and abbreviated new drug applications; technical amendment. Final rule; technical amendment.
    Food and Drug Administration, HHS
    Fed Regist; 2009 Mar; 74(43):9765-6. PubMed ID: 19418639
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2007 Oct; 72(201):58993-9000. PubMed ID: 17966558
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Jul; 73(133):39588-611. PubMed ID: 18850675
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Investigational new drug, antibiotic, and biological product applications; clinical hold and termination--FDA. Final rule.
    Fed Regist; 1992 Apr; 57(73):13244-9. PubMed ID: 10118458
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Current good manufacturing practice regulation and investigational new drugs. Direct final rule.
    Food and Drug Administration. HHS
    Fed Regist; 2006 Jan; 71(10):2458-62. PubMed ID: 16479693
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Amendment to examination and investigation sample requirements--FDA. Direct final rule.
    Fed Regist; 1998 Sep; 63(186):51297-9. PubMed ID: 10185810
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Human drugs and biologics; determination that informed consent is NOT feasible or is contrary to the best interests of recipients; revocation of 1990 interim final rule; establishment of new interim final rule. Food and Drug Administration, HHS. Interim final rule; opportunity for public comment.
    Fed Regist; 1999 Oct; 64(192):54180-9. PubMed ID: 11010702
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Human subject protection; foreign clinical studies not conducted under an investigational new drug application. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2008 Apr; 73(82):22800-16. PubMed ID: 18567164
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 12.